Other regulatory functions

Internal reviews

The APVMA had no internal review due in the June quarter 2018. There were 3 internal reviews active at the end of the June quarter 2018.

Internal reviews—June quarter 2018

Quarter

Decision Due within the Qtr

Finalised within the Qtr

Finalised that were due within the Qtr

Finalised within timeframe (%)

Sep 2017

0

2

N/A

N/A

Dec 2017

1

4

0

0

Mar 2018

0

1

0

0

 
Jun 2018 0 0 0 N/A

If an applicant is not satisfied with a decision made by the APVMA an internal review can be requested. These must be completed within 90 days.

Chemical reviews

A chemical review or ‘chemical reconsideration’ is where the APVMA reconsiders the registration of a chemical, if risks to safety and performance have been identified.

The APVMA continued to progress component assessments for the remaining fifteen chemical reviews.

On 28 March 2018 the Macrolide antibiotics review was completed and the regulatory decision report was published on 6 April 2018.

On 28 May 2018 the Polihexanide review was completed and the regulatory decision report was published.

GMP audit program

In the June quarter 2018, the APVMA completed 30 Good Manufacturing Practice (GMP) audits—22 in Australia and 8 overseas—with 82 per cent of GMP audits completed within timeframe.

GMP activity—June quarter 2018

Quarter

Audit location

Number completed

Within timeframe

Within one week of due date

Sep 17

Australia

15

93.3%

100%

Overseas

6

100%

100%

Dec 17

Australia

7

85.7%

100%

Overseas

4

50%

50%

Mar 18

Australia

9

89%

100%

Overseas

1

100%

100%

Jun 18

Australia

22

73%

82%

Overseas

8

88%

88%

Total

72

82%

89%

Good Manufacturing Practice (GMP) is part of quality assurance in the manufacturing process and relates to both production and quality control.

Compliance statutory notices

There were no statutory notice published in the June quarter 2018.

Notices issued—December quarter 2017

Quarter

Issued

Finalised

Within timeframe

Sep 17

0

0

N/A

Dec 17

1*

0

N/A

Mar 18

0

0

N/A

Ju 18 0 0 N/A

Total

1*

0

N/A

 

*Notice published following determination of the Administrative Appeals Tribunal.

Compliance statutory notices are formal correspondence issued periodically throughout the year from the APVMA under the agvet code and include stop supply or recall notices or substantiation notices.

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